131 i-mibg in treating patients with refractory or relapsed neuroblastoma

Conditions: Neuroblastoma

Summary: rationale: radioactive drugs, such as 131 i-mibg, may carry radiation directly to tumor cells and not harm normal cells. purpose: this phase ii trial is studying how well 131 i-mibg works in treating patients with refractory or relapsed neuroblastoma.

objectives: primary * determine if iodine i 131 metaiodobenzylguanidine can provide palliative therapy for patients with refractory or relapsed neuroblastoma. * determine the acute and late toxicity of this regimen in these patients. secondary * determine disease and symptom responses of patients treated with this regimen. outline: this is a compassionate use study. patients receive iodine i 131 metaiodobenzylguanidine iv over 2 hours. beginning 10 days later, patients with low neutrophil counts receive filgrastim (g-csf) subcutaneously until blood count recovers. patients with stable or responding disease may receive a second dose of iodine i 131 metaiodobenzylguanidine at least 6 weeks after the first dose. after completion of study treatment, patients are followed periodically. projected accrual: a total of 50 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * original diagnosis of neuroblastoma based on 1 of the following criteria: * histopathology * elevated urine catecholamines with typical tumor cells in the bone marrow * refractory or relapsed disease, meeting 1 of the following criteria: * failure to respond to standard therapy (e.g., combination chemotherapy with or without radiotherapy and surgery) * evidence of disease progression (i.e., any new lesion or an increase in size of \> 25% of a pre-existing lesion) at any time * evaluable disease by mibg scan within 6 weeks of study entry patient characteristics: * not pregnant or nursing * fertile patients must use effective contraception * negative pregnancy test * bilirubin \< 2 times normal * ast/alt ≤ 10 times normal * creatinine ≤ 2 mg/dl * absolute neutrophil count\* ≥ 750/mm\^3 (transfusion independent) * platelet count\* ≥ 50,000/mm\^3 (20,000/mm\^3 if stem cells are available and platelet transfusion independent) * hemoglobin\* ≥ 10 g/dl (transfusion allowed) * no dyspnea at rest * no exercise intolerance * no oxygen requirement * no clinically significant cardiac dysfunction * no disease of any major organ system that would preclude study compliance * no active infection that meets grade 3 or 4 toxicity criteria note: \*patients with granulocytopenia and/or thrombocytopenia due to tumor metastases to the bone marrow may be eligible at the discretion of the principal investigator prior concurrent therapy: * see disease characteristics * recovered from prior therapy * at least 2 weeks since prior antitumor therapy * at least 3 months since prior radiotherapy to any of the following fields: * craniospinal * total abdominal * whole lung * total body * at least 1 day since prior cytokine therapy (e.g., filgrastim \[g-csf\], sargramostim \[gm-csf\], interleukin-6, or epoetin alfa) * prior iodine i 131 metaiodobenzylguanidine allowed provided it was given more than 6 months ago and patient has adequate hematopoietic stem cells available * no concurrent hemodialysis

Keywords: recurrent neuroblastoma